IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system

The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in...

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Veröffentlicht in:Journal of pharmaceutical sciences 2009-06, Vol.98 (6), p.2001-2009
Hauptverfasser: Buch, Philipp, Langguth, Peter, Kataoka, Makoto, Yamashita, Shinji
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container_end_page 2009
container_issue 6
container_start_page 2001
container_title Journal of pharmaceutical sciences
container_volume 98
creator Buch, Philipp
Langguth, Peter
Kataoka, Makoto
Yamashita, Shinji
description The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and Cmax of fenofibric acid. This study thus demonstrates the potential of the D/P system as valuable tool for absorption screening of dosage forms for poorly soluble drugs. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2001–2009, 2009
doi_str_mv 10.1002/jps.21576
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Pharm. Sci</addtitle><description>The usefulness of a dissolution/permeation (D/P) system to predict the in vivo performance of solid dosage forms containing the poorly soluble drug, fenofibrate, was studied. Biorelevant dissolution media simulating the fasted and fed state conditions of the human gastrointestinal tract were used in order to simulate the effect of food on the absorption of fenofibrate. Moreover, the results obtained from the D/P system were correlated with pharmacokinetic parameters obtained following in vivo studies in rats. The in vitro parameter (amount permeated in the D/P system) reflected well the in vivo performance in rats in terms of AUC and Cmax of fenofibric acid. 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Pharmaceutical industry</subject><subject>Pharmacology. 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subjects Absorption
Administration, Oral
Animals
Biological and medical sciences
biopharmaceutics classification system (BCS)
Caco-2 Cells
Chemistry, Pharmaceutical - instrumentation
Chemistry, Pharmaceutical - methods
dissolution
Fenofibrate - blood
Fenofibrate - chemistry
Fenofibrate - metabolism
Fenofibrate - pharmacokinetics
food-effect-studies
General pharmacology
Humans
Hypolipidemic Agents - blood
Hypolipidemic Agents - chemistry
Hypolipidemic Agents - metabolism
Hypolipidemic Agents - pharmacokinetics
in vitro/in vivo correlations (IVIVC)
Male
Medical sciences
Permeability
permeation
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Rats
Rats, Wistar
Solubility
Tablets - chemistry
Tablets - metabolism
Tablets - pharmacokinetics
title IVIVC in oral absorption for fenofibrate immediate release tablets using a dissolution/permeation system
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